SAN DIEGO, February 27, 2007 /PRNewswire-FirstCall/ -- An
allergy medicine currently under review by the Food and Drug
Administration was effective and well-tolerated in treating a range
of nasal allergy symptoms such as congestion, sneezing, itchy and
runny nose, according to clinical studies presented at the annual
meeting of the American Academy of Allergy, Asthma & Immunology
(AAAAI).

In two separate Phase III clinical studies (poster #1190, 908,
910, and 906), fluticasone furoate nasal spray (FFNS) was more
effective than placebo in relieving both the nasal and eye symptoms
of patients 12 years and older with seasonal allergic rhinitis,
commonly known as hay fever. One additional Phase III study (poster
#254) among individuals with perennial allergic rhinitis --
year-round nasal allergies -- found FFNS to be more effective than
placebo in relieving nasal symptoms. What's more, the
symptom-relief lasted 24 hours in all three studies.

"These studies are promising for millions of patients who
continue to seek relief for their allergy symptoms," said Robert
Nathan, M.D., Allergy & Asthma Associates, Colorado Springs,
CO, who led one of the studies. "Seasonal and perennial allergies
have a significant impact on quality of life, so new, effective
medications would be welcomed," he added.

The Data: Seasonal Allergic Rhinitis

Researchers presented two randomized, double-blind,
placebo-controlled trials of the effect of FFNS 110 mcg once daily
on nasal and eye symptoms in patients with seasonal allergic
rhinitis. The results of the studies were detailed in four poster
presentations.

Poster #1190 (Hampel et al.): In a study of 302 individuals, age
12 and older, allergic to mountain cedar pollen, FFNS was
significantly more effective than placebo in relieving nasal
congestion, itching, runny nose, and sneezing. On a validated
patient-rated scale of nasal symptoms, the mean change from
baseline was -3.03 for FFNS vs. -2.25 for placebo (p=0.003). FFNS
was also associated with sustained 24-hour relief from nasal
symptoms, as measured by the mean change from baseline in next-day
pre-dose symptom scores (-2.38 for FFNS vs. -1.47 for placebo;
p<0.001).

Poster #908 (Ratner et al.): In the same seasonal allergic
rhinitis study of 302 patients allergic to mountain cedar pollen,
FFNS was significantly more effective than placebo in relieving
such eye symptoms as burning or itching, redness, and watering or
tearing. On a validated patient-rated scale of eye symptoms, the
mean change from baseline was -2.15 for patients in the FFNS group
vs. -1.60 for patients in the placebo group (p=0.008). As with
nasal symptoms, eye-symptom relief was sustained for 24 hours, as
measured by mean change from baseline in next-day pre-dose symptoms
scores (-1.57 for patients in the FFNS group vs. -1.05 for patients
in the placebo group; p=0.009).

Poster #910 (Kaiser et al.): In a second study in seasonal
allergic rhinitis -- this one in 299 patients allergic to ragweed
-- treatment with FFNS was associated with significantly greater
improvement in nasal symptoms compared with placebo. Using the same
validated patient self-scoring system, the mean change from
baseline in the total scores of nasal congestion, itching, runny
nose, and sneezing was -3.55 for FFNS vs. -2.07 for placebo
(p<0.001). Moreover, efficacy was sustained over 24 hours (-2.90
for FFNS vs. -1.53 for placebo; p<0.001), and the onset of
relief was eight hours after the first dose (p=0.028). Maximum
benefit required several days of treatment.

Poster #906 (Lumry et al.): In the same study of 299
ragweed-allergic patients, those who received FFNS had significant
improvement in eye symptoms (-2.23 for FFNS vs. -1.63 for placebo;
p=0.004), that was sustained over 24 hours (-1.86 for FFNS vs.
-1.30 for placebo; p=0.007). "These are the first two
prospectively-designed Phase III studies to demonstrate consistent
and significant improvement in eye-related allergy symptoms with an
intranasal steroid," commented lead investigator William R. Lumry,
M.D., Asthma & Allergy Specialists, Dallas, TX.

The Data: Perennial Allergic Rhinitis

Poster #254 (Nathan et al.): To test the effectiveness of FFNS
in patients with perennial allergic rhinitis, researchers conducted
a randomized, double-blind, placebo-controlled trial of once-daily
FFNS 110 mcg in 302 patients. After four weeks of treatment,
patients randomized to FFNS experienced significantly fewer nasal
symptoms than did those who took placebo. The mean change from
baseline on the validated patient self-scoring system was -2.78 for
the FFNS group vs. -2.08 for the placebo group (p=0.005). FFNS
patients also experienced sustained 24-hour relief, compared with
those in the placebo group (-2.45 for FFNS vs. -1.75 for placebo;
p=0.006).

FFNS was well-tolerated and no drug-related serious adverse
events were identified in these SAR and PAR studies. The most
common adverse events reported were headache and nosebleed. In both
the PAR study and the mountain cedar SAR study, the most common
adverse event in both groups was headache, and the most common
drug-related adverse event was nosebleed. In the ragweed SAR study,
headache was the most common drug-related adverse event, followed
by nosebleed.

About FFNS

Fluticasone furoate nasal spray is an enhanced affinity
intranasal corticosteroid (INS) currently in development by
GlaxoSmithKline (GSK) for use in the treatment of the symptoms of
allergic rhinitis. As an INS, fluticasone furoate blocks the action
of inflammatory mediators early in and throughout the allergy
process. FFNS has a unique, side-actuated trigger designed for
ease-of-use and patient comfort. The new agent is currently under
review by the U.S. Food and Drug Administration to treat the
symptoms of seasonal allergic rhinitis (SAR) and perennial allergic
rhinitis (PAR).

INS

Intranasal corticosteroids (INSs) effectively reduce the nasal
inflammation that is a root cause of allergic rhinitis. By acting
early and throughout the allergy process, INSs block many allergy
mediators, treating the symptoms caused by nasal inflammation such
as nasal congestion, sneezing, and runny or itchy nose. This class
of medicine is considered first-line therapy when nasal congestion
is the primary symptom of the patient's rhinitis.

About Allergic Rhinitis

Allergic rhinitis (AR), known as nasal allergies, is an
inflammatory reaction of the nasal passages to allergens, such as
dust mites, animal dander, mold spores, and pollens. One of the
most prevalent and chronic diseases in the U.S., nasal allergies
affect up to 40 million people annually, including 10 to 30 percent
of adults and up to 40 percent of children. Within minutes of
exposure to an allergen, immune response cells release inflammatory
mediators -- such as histamines and leukotrienes -- that lead to
inflammation and produce symptoms including nasal congestion,
sneezing and runny or itchy nose. Seasonal allergic rhinitis,
triggered by pollens, occurs during certain seasons and lasts a few
weeks to a few months. Perennial allergic rhinitis, triggered by
dust mites, animal dander, and mold, occurs year-round.

About GlaxoSmithKline

GlaxoSmithKline is one of the world's leading research-based
pharmaceutical and healthcare companies. GlaxoSmithKline is
committed to improving the quality of human life by enabling people
to do more, feel better, and live longer. For company information
visit www.gsk.com.

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